(1) Field of the Invention
The present invention relates to certain new and useful improvements in aiding the comfort of breast engorgement pain and breast milk suppression and, more particularly, to an improved apparatus and method residing in the provision of a specified patch which is worn over a woman's chest to aid engorgement pain and suppression of breast milk
(2) Description of the Related Art
This invention endeavors to provide a safe, comfortable, easy to use device to relieve the pain and discomfort associated with postpartum breast milk engorgement, to expedite the suppression of lactation for women who choose not to breast-feed, and to aid in the treatment of prolactin dependent and related diseases and disorders. This is accomplished by inhibiting the production of prolactin which suppresses lactation.
After pregnancy, a woman naturally produces breast milk for a period of time. The length of time for postpartum milk production varies depending upon whether or not the mother breast-feeds and how long she breast-feeds. For breast-feeding mothers, milk production can continue up to twenty four months or longer. For non-breast-feeding women, the duration is impacted by whether or not and for how long her breasts were pumped or stimulated to produce milk. Women who choose not to breast-feed experience discomfort and pain due to breast engorgement. Relief is sought through breast pumping stimulation, which prolongs production and delays suppression of milk production; ice packs; breast binding, which can cause mastitis; and various other means that have proven to be dangerous or otherwise unsuccessful.
According to Treatment for Lactation Suppression, Little Progress in One Hundred Years (Am J Obstet. Gynecol. 1998; 179:1485-90) “Engorgement and breast pain may encompass most of the first postpartum week. Up to one third of women who do not breast-feed and who use a brassiere or binder, ice packs, or analgesics may experience severe breast pain. Specific studies of nonpharmacologic methods of lactation suppression were limited and inconclusive. Available data suggest that many women using currently recommended strategies for treatment of symptoms may nevertheless experience engorgement or pain for most of the first postpartum week.
There is no Federal Drug Administration (FDA) approved treatment for the relief of breast milk engorgement pain. Prescription drugs such as, Parlodel® (bromocriptine mesylate), a previously FDA approved lactation suppressant and estrogens and androgens (gonadotrophic hormones) have been prescribed and are possibly still being used as a prolactin inhibitor to suppress milk production for breast engorgement relief and to treat prolactin related disease and conditions.
Parlodel® inhibits the secretion of the hormone, prolactin, from the pituitary gland. It also mimics the action of dopamine, a chemical lacking in the brain of a person with Parkinson's disease. Parlodel®, and estrogens and androgens have been used to treat a variety of medical conditions, including lactation suppression, infertility, menstrual problems (such as galactorrhea), and prolactin dependent amenorrhea, with or without excessive production of milk. However, it has been well documented in the literature that these drugs and hormones have produced adverse effects including death. Some of the documentation is in the literature that follows.
To address problems involved in the prior art, reference is made to the Dec. 1, 1989 FDA Consumer which states “FDA has asked that the manufacturer of the drug Parlodel® (bromocriptine) to stop labeling the drug for use in drying up milk production and preventing breast engorgement in mothers who don't breast-feed. (Parlodel® is approved for treatment of Parkinson's disease.)
In a related move, FDA requested that the manufacturers of products containing estrogen and androgens stop labeling these gonadotrophic hormones as lactation suppressants. FDA's Fertility and Maternal Health Drugs Advisory Committee suggested the changes, in part, because these drugs, which can have serious side effects, benefit only 10 percent of the women who use them to suppress lactation. Also, the drugs' effectiveness is diminished because of the high occurrence of rebound. Breasts become engorged again after the woman stops taking the drugs.
The Health facts newspaper (Sep. 1, 1994, edition) states “Parlodel®, a drug widely used to suppress breast milk following childbirth has finally been withdrawn by its manufacturer, Sandoz, five years after it was found to be dangerous and ineffective.” The action came on the heels of a national TV investigative report and a lawsuit against the FDA by the Public Citizen's Health Research Group and the National Women's Health Network.
The two consumer groups took legal action against the FDA because the agency failed to ban the drug as a lactation suppressant after receiving reports of its dangers. Since 1980, according to Public Citizen, the FDA had received 531 adverse reactions reports, including 32 deaths, 14 from stroke and five heart attacks. Among the nonfatal reactions, there were 36 strokes, 14 heart attacks, and 98 seizures; many of these cases involve permanent disability. Underreporting is a very real possibility as the FDA's post market surveillance system is notoriously weak (Rx News August 1994).”
In the Oct. 1, 1994, issue of Trial Magazine, it is stated “Under a barrage of consumer criticism and a lawsuit, the manufacturer of Parlodel® said it will no longer market the drug as a lactation suppressant. The drug has been blamed for the deaths of at least 32 new mothers and for medical problems in hundreds of women since it received U.S. Food and Drug Administration (FDA) approval in 1980.”
In the United States, the sharp restriction in the use of pharmaceuticals to aid the suppression of breast milk and the discomfort and pain from engorgement, has resulted in essentially no recognized mechanism for lactation suppression and relieving the discomfort of breast milk engorgement. The formerly used pharmaceutical items are no longer available as a prescription for lactation suppression. They are however, offered online through Canadian and United Kingdom Pharmacies without a prescription. This availability again exposes mothers to the serious documented risks. Accordingly, there is an urgent need for an alternative method which will relieve the discomfort of breast engorgement pain and expedite the suppression of breast milk production in a safe, convenient, efficient, and legal manner.
“There is increasing evidence that prolactin (PRL), a hormone/cytokine, plays a role in breast, prostate, and colorectal cancers via local production or accumulation.” (Cancer Res. 2009; 69(12):5226-33) Breast cancer is the most common cancer among American women, except for skin cancers. The chance of developing invasive breast cancer at some time in a woman's life is a little less than 1 in 8 (12%). Breast cancer is the second leading cause of cancer death in women, exceeded only by lung cancer.” (American Cancer Society, Dec. 9, 2011) “Other than skin cancer, prostate cancer is the most common cancer in American men. About 1 man in 6 will be diagnosed with prostate cancer during his lifetime. Prostate cancer is the second leading cause of cancer death in American men, behind only lung cancer.” (American Cancer Society Oct. 12, 2011)
Current treatment of prolactin dependent and related diseases and conditions involves the use of neutralizing prolactin receptor antibodies and antigen binding fragments, through pharmaceutical agents including dopamine antagonists and monoclonal drugs. These pharmaceutical drugs affect the amino acid sequence of the extracellular domain of the prolactin receptor and the nucleic acid sequence whereby the pharmaceutical composition antagonizes the prolactin receptor mediated signaling. (US Fed. News Service, Including US State News, Jun. 16, 2011, WIPO Assigns patent To Bayer Schering Pharma. for “Neutralizing Prolactin Receptor Antibodies and their therapeutic use.” abstract). Recent studies indicate “Several PRL receptor (PRLR) antagonists have been identified in the past decades, but their in vivo growth inhibitory potency was restricted by low receptor affinity, rendering them pharmacologically unattractive for clinical treatment.” PEDS Oxford Journals; Life Sciences & Medicine; Volume 24, Issue 11